IEC Functional Safety Assessment
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1 IEC Functional Safety Assessment Project: DeltaV SIS DeltaV SIS Relay Module, KJ2231X1- EA1 DeltaV SIS Voltage Monitor, KJ2231X1 EB1 Customer: Emerson Process Management Fisher Rosemount Systems Austin, TX USA Contract No.: Q07/11-05 Report No.: FRS R002 Version V1, Revision R2, July 1, 2008 Michael Medoff The document was prepared using best effort. The authors make no warranty of any kind and shall not be liable in any event for incidental or consequential damages in connection with the application of the document. All rights reserved.
2 Management summary This report summarizes the results of the functional safety assessment according to IEC carried out on the: DeltaV SIS DeltaV SIS Relay Module, KJ2231X1- EA1 DeltaV SIS Voltage Monitor, KJ2231X1 EB1 The functional safety assessment performed by exida consisted of the following activities: - exida assessed the modifications performed by Emerson by an on-site audit and creation of a detailed safety case against the requirements of IEC These products were previously certified to IEC 61508, SIL 3 (See [D10]). Based on this certification, it can be concluded that the Emerson development process meets the requirements of IEC for SIL 3. As a result this latest assessment focused on reviewing the changes made to the product. The changes were assessed against section 7.8 of IEC part 2 (E/E/PES Modification) and section 7.8 of part 3 (Software Modification). A partial IEC Safety Case was prepared, focusing specifically on the modification process, and used as the primary audit tool. Modification process requirements and all associated documentation were reviewed. See section 3 of this document for details on which hardware and software versions have been included in this assessment. The results of the Functional Safety Assessment can be summarized by the following statements: The DeltaV SIS, DeltaV SIS Relay Module and DeltaV SIS Voltage Monitor were found to meet the requirements of SIL 3, single use (HFT = 0). Michael Medoff Page 2 of 18
3 Table of Contents Management summary Purpose and Scope Project management exida Roles of the parties involved Standards / Literature used Reference documents Documentation provided by Emerson Process Management Documentation generated by exida Product Description DeltaV SIS Logic Solver DeltaV SIS Relay Module DeltaV SIS Voltage Monitor IEC Functional Safety Assessment Methodology Assessment level Results of the IEC Functional Safety Assessment Detailed Specification of the Modification or Change (Part 2, Section a) Impact Analysis (Part 2, Section b) Approvals for changes (Part 2, Section c) Progress of Changes (Part 2, Section d) Test Cases Including Revalidation Data (Part 2, Section e) E/E/PES configuration management history (Part 2, Section f) Deviation from normal operations and conditions (Part 2, Section g) Necessary changes to system procedures (Part 2, Section h) Necessary changes to documentation (Part 2, Section i) Modifications shall be performed with at least the same level of expertise, automated tools (see of IEC ), and planning and management as the initial development of the E/E/PE safety-related systems (Part 2, Section ) Evidence that Change was re-verified (Part 2, Section ) For SIL 3, Entire System Must be validated (Table A.8) A modification shall be initiated only on the issue of an authorized software modification request under the procedures specified during safety planning (Part 3, Section ) All modifications which have an impact on the functional safety of the E/E/PE safetyrelated system shall initiate a return to an appropriate phase of the software safety lifecycle. All subsequent phases shall then be carried out in accordance with the procedures specified for the specific phases in accordance with the requirements in this Michael Medoff Page 3 of 18
4 standard. Safety planning (see clause 6) should detail all subsequent activities (Part 3, Section ) The safety planning for the modification of safety-related software shall include identification of staff and specification of their required competency. (Part 3, a) The safety planning for the modification of safety-related software shall include a detailed specification for the modification (Part 3, Section b) The safety planning for the modification of safety-related software shall include verification planning (Part 3, Section c) The safety planning for the modification of safety-related software shall include the scope of re-validation and testing of the modification to the extent required by the safety integrity level. For SIL 3 entire system must be revalidated. (Part 3, Section d) Modification shall be carried out as planned (Part 3, Section ) Details of all modifications shall be documented, including references to the modification/retrofit request (Part 3, Section a) Details of all modifications shall be documented, including references to the results of the impact analysis which assesses the impact of the proposed software modification on the functional safety, and the decisions taken with associated justifications; (Part 3, Section b) Details of all modifications shall be documented, including references to software configuration management history (Part 3, Section c) Details of all modifications shall be documented, including references to deviation from normal operations and conditions (Part 3, Section d) Details of all modifications shall be documented, including references to all documented information affected by the modification activity (Part 3, Section e) Information (for example a log) on the details of all modifications shall be documented. The documentation shall include the re-verification and revalidation of data and results. (Part 3, Section ) The assessment of the required modification or retrofit activity shall be dependent on the results of the impact analysis and the software safety integrity level. (Part 3, Section ) Hardware Assessment Terms and Definitions Status of the document Liability Releases Future Enhancements Release Signatures Michael Medoff Page 4 of 18
5 1 Purpose and Scope Generally four options exist when doing an assessment of sensors, logic solvers and/or final elements. Option 1: Hardware assessment according to IEC Option 1 is a hardware assessment by exida according to the relevant functional safety standard(s) like IEC or EN The hardware assessment consists of a FMEDA to determine the fault behavior and the failure rates of the device, which are then used to calculate the Safe Failure Fraction (SFF) and the average Probability of Failure on Demand (PFD AVG ). This option shall provide the safety instrumentation engineer with the required failure data as per IEC / IEC and does not include an assessment of the development process. Option 2: Hardware assessment with proven-in-use consideration according to IEC / IEC Option 2 is an assessment by exida according to the relevant functional safety standard(s) like IEC or EN The hardware assessment consists of a FMEDA to determine the fault behavior and the failure rates of the device, which are then used to calculate the Safe Failure Fraction (SFF) and the average Probability of Failure on Demand (PFD AVG ). In addition, this option includes an assessment of the proven-in-use demonstration of the device and its software including the modification process. This option for pre-existing (programmable electronic) devices shall provide the safety instrumentation engineer with the required failure data as per IEC / IEC and justify the reduced fault tolerance requirements of IEC for sensors, final elements and other PE field devices. Option 3: Full assessment according to IEC Option 3 is a full assessment by exida according to the relevant application standard(s) like IEC or EN 298 and the necessary functional safety standard(s) like IEC or EN The full assessment extends option 1 by an assessment of all fault avoidance and fault control measures during hardware and software development. Option 4: Assessment of Modifications according to IEC for previously certified products Option 4 only applies to products that have already been certified to and have undergone changes. The changes are assessed specifically against the modification sections of IEC (Section 7.8 of part 2 and 7.8 of part 3). This assessment shall be done according to option 4. This document shall describe the results of the IEC functional safety assessment of the DeltaV SIS, DeltaV SIS Relay Module, and DeltaV SIS Voltage Monitor. Michael Medoff Page 5 of 18
6 2 Project management 2.1 exida exida is one of the world s leading knowledge companies specializing in automation system safety and availability with over 200 years of cumulative experience in functional safety. Founded by several of the world s top reliability and safety experts from assessment organizations like TUV and manufacturers, exida is a partnership with offices around the world. exida offers training, coaching, project oriented consulting services, internet based safety engineering tools, detail product assurance and certification analysis and a collection of on-line safety and reliability resources. exida maintains a comprehensive failure rate and failure mode database on process equipment. 2.2 Roles of the parties involved Emerson Process Management exida Manufacturer of the DeltaV SIS, DeltaV SIS Relay Module, and DeltaV SIS Voltage Monitor Performed the IEC Functional Safety Assessment according to option 4 (see section 1) Emerson Process Management contracted exida in December 2007 with the IEC Functional Safety Assessment of the above mentioned devices. 2.3 Standards / Literature used The services delivered by exida were performed based on the following standards / literature. [N1] IEC (Parts 1-7): 2000 Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems 2.4 Reference documents Documentation provided by Emerson Process Management [D1] ImpactAnalysis_080318_10_3_SLS.doc DeltaV SIS Impact Analysis Report [D2] Reduced Status Boolean Design.docx Design for Reduced Status Booleans [D3] SIS_LSDVC_RevN.xls DeltaV SIL_LSDVC_Block Plan and Results [D4] HighDensity_ SIS_SLS_Fault_Detection_RevJ.xls Test DeltaV SIS_SLS_Fault_Detectio n Test Plan and Results [D5] SIS_SLS_Fault_Detection_RevI.xls DeltaV SIS_SLS_Fault_Detectio n Test Plan and Results 03/27/ /15/200 8 Rev N Rev J Rev I Michael Medoff Page 6 of 18
7 [D6] SIS_Validation_Blocks_RevO.xls DeltaV SIS_Validation_Blocks Test Plan and Results Rev O [D7] Incident_90431.txt Incident Report /22/2008 [D9] SIS_Validation_System_RevL.xls SIS_Validation_System Test Plan Rev L [D10] FRS R001 IEC Functional Safety Assessment Report for DeltaV SIS. V1R1 [D11] Incident_90899.txt Incident Report /22/2008 [D12] Review_3597.pdf [D13] Review_3639.pdf SIS Reduced Status Boolean Concept Design Review Minutes Reduced Status Booleans SLS Design Review Minutes 1/16/2008 2/7/2008 [D14] Review_3657.pdf Code Review Minutes 2/18/2008 [D15] Review_3739.pdf Software Impact Analysis Review Minutes 3/28/2008 [D16] V210x_Formal_Module_Tests.docx Module Test Results 5/21/2008 [D17] V210x_Informal_Module_Tests.docx Module Test Results 5/21/2008 [D18] V210x_Lint_Results PC Lint Results 3/13/2008 [D19] ControlDevice_FMT.doc Module Test Results 2/13/2008 [D20] ControlIOBlock_FMT.doc Module Test Results 3/13/2008 [D21] ControlMsgRouter_FMT.doc Module Test Results 2/13/2008 [D22] ControlSecureWrite_FMT.doc Module Test Results 2/13/2008 [D23] FMT_DiagSSMonitor.doc Module Test Results 2/13/2008 [D24] Review_3657.bmp Code Review Minutes 2/18/2008 [D25] DS Delta V SIS Simulate for SIS enhancements As-built.doc [D26] V2105_SIS_Integration_Test_Results_ xl s Direction Statement for release 3/18/2008 Integration Test Results 6/6/2008 Michael Medoff Page 7 of 18
8 2.4.2 Documentation generated by exida [R1] DeltaV Change Audit.xls Detailed safety case documenting results of assessment (internal document) [R2] Emerson R002 V1 R1 IEC Assessment.doc IEC Functional Safety Assessment, DeltaV SIS (this report) Michael Medoff Page 8 of 18
9 3 Product Description The DeltaV SIS SLS1508 is a safety logic solver. The DeltaV SLS1508 is classified as a Type B 1 device according to IEC 61508, having a hardware fault tolerance of 0. DeltaV SIS Relay Module and DeltaV SIS Voltage Monitor are accessories that can be used with the DeltaV SLS1508 logic solver. The DeltaV SIS Relay Module, and DeltaV SIS Voltage Monitor are classified as Type A 2 devices according to IEC 61508, having a fault tolerance of 0. Fisher-Rosemont Systems, Inc. is the original designer and manufacturer of the DeltaV SIS, DeltaV SIS Relay, and DeltaV SIS Voltage Monitor modules. 3.1 DeltaV SIS Logic Solver The DeltaV SIS Logic Solver is a compact logic solver that can handle up to 16 I/O channels in any combination of HART AI, HART AO, DI and DO including line fault detection on all I/O. The DeltaV SLS1508 hardware version considered is 4.0 or higher and the software version considered is or higher. 3.2 DeltaV SIS Relay Module The DeltaV SIS Relay Module (model number KJ2231X1- EA1) is suitable for use in both high and low demand de-energize to trip safety applications, to extend the voltage and current capability of the DeltaV SLS1508 discrete output. It is capable of switching up to 2.5A at 250VAC or 2.5A at 24VDC for safety applications following de-energize to trip conventions by disconnecting field power when de-energized. Two sets of output switches are provided controlled by one common input. DC Mode of operation is configured to provide two independent sets of DC input power while the AC mode of operation is configured to switch both sides of the AC input power. The DeltaV SIS Relay Module contains three relays from different manufacturers. A relay coil is energized for all three relays in normal operation. If a demand occurs, the SLS1508 removes the power from the coil for all three relays at the same time. Each relay can be proof tested. The DeltaV SIS Relay Module hardware revision considered is revision A or higher. 1 Type B sub(system): Complex sub(system) (using microcontrollers or programmable logic); for details see of IEC Type A sub(system): Non-complex sub(system) with well defined failure modes; for details see of IEC Michael Medoff Page 9 of 18
10 3.3 DeltaV SIS Voltage Monitor The DeltaV SIS Voltage Monitor (model number KJ2231X1 EB1) provides two independent sets of voltage monitoring circuitry in one device where each is suitable for use in both high and low demand de-energize to trip applications to extend the voltage input monitoring capability of the SLS1508. It also supplies a secondary output for non-safety critical monitoring for each input. The state of both outputs for an associated input is controlled by the voltage level of the input with the outputs going to the de-energized state when the input goes below a specified value. It is designed to be used with DeltaV SLS1508 to drive a logic solver s discrete input channel or a series 2 DI dry contact channel based on the output of the SIS Relay Module. The Voltage Monitor has the following connections: Two four pin connection blocks, one for each voltage monitoring channel for connection to DC or AC power source being monitored. Two four pin connection blocks, one for each voltage monitoring channel for connecting the output to a SLS monitored DI channel and a DI, dry contact channel. The DeltaV SIS Voltage Monitor hardware revision considered is revision A or higher. Michael Medoff Page 10 of 18
11 4 IEC Functional Safety Assessment The IEC Functional Safety Assessment was performed based on the information received from Emerson and is documented here. 4.1 Methodology The full functional safety assessment includes an assessment of a representative subset of all changes made in comparison to the modification requirements of IEC (Section 7.8 of part 2 and 7.8 of part 3). 4.2 Assessment level The DeltaV SIS, DeltaV SIS Relay Module, and DeltaV SIS Voltage Monitor has been assessed per IEC to Safety Integrity Level 3. The development procedures have been previously assessed as suitable for use in applications with a maximum Safety Integrity Level of 3 (SIL3) according to IEC (see [D10]) Michael Medoff Page 11 of 18
12 5 Results of the IEC Functional Safety Assessment exida assessed the changes made by Emerson for this development against the modification procedures of IEC parts 2 and 3. The assessment was done remotely in May and June of Additionally, a detailed safety case was completed. The specific part of and section number are given in parenthesis for each item below. A representative subset of all changes were successfully reviewed against the following criteria from IEC 61508: 5.1 Detailed Specification of the Modification or Change (Part 2, Section a) Detailed specifications of all modifications are included in the impact analysis document and in the Issue Tracking Database. 5.2 Impact Analysis (Part 2, Section b) All changes include a detailed safety impact analysis. The impact analysis details which phases of the development process need to be repeated and what output is required from each phase. The impact analysis is documented in an independent document (See [D1]). A listing of all changed software modules is included in the review database (See [D24]). 5.3 Approvals for changes (Part 2, Section c) Approvals for all changes are documented in the issue tracking database. 5.4 Progress of Changes (Part 2, Section d) Progress of all changes is documented via the change history in the issue tracking database. 5.5 Test Cases Including Revalidation Data (Part 2, Section e) Integration test cases are documented in the issue tracking database. Validation test cases are documented in the validation test plans. 5.6 E/E/PES configuration management history (Part 2, Section f) Configuration Management history is documented via the version control system for all changes. In addition, all documents include the configuration management history within the document. 5.7 Deviation from normal operations and conditions (Part 2, Section g) Deviations from normal operations and conditions is discussed in the impact analysis for all changes Michael Medoff Page 12 of 18
13 5.8 Necessary changes to system procedures (Part 2, Section h) Any changes to system procedures are documented in the impact analysis. 5.9 Necessary changes to documentation (Part 2, Section i) All necessary documentation changes are included in the impact analysis 5.10 Modifications shall be performed with at least the same level of expertise, automated tools (see of IEC ), and planning and management as the initial development of the E/E/PE safety-related systems (Part 2, Section ) Management assures that changes are carried out by qualified engineers. For this project, all engineers had been involved in the initial development. The Project Plan documents which fixes will be assigned to each release. The issue tracking system is used to track work assignments. Identical tools to the original development were used Evidence that Change was re-verified (Part 2, Section ) All changes had appropriate verification steps carried out. Verification included inspection, testing, and static analysis. Action items from inspections were tracked to closure For SIL 3, Entire System Must be validated (Table A.8) Complete validation test plan was run successfully after the changes were made (See [D3] through [D9]) 5.13 A modification shall be initiated only on the issue of an authorized software modification request under the procedures specified during safety planning (Part 3, Section ) All software changes are submitted to the issue tracking system and authorized by the development manager All modifications which have an impact on the functional safety of the E/E/PE safety-related system shall initiate a return to an appropriate phase of the software safety lifecycle. All subsequent phases shall then be carried out in accordance with the procedures specified for the specific phases in accordance with the requirements in this standard. Safety planning (see clause 6) should detail all subsequent activities (Part 3, Section ) The impact analysis documents which phases need to be repeated and the phases are carried out according to standard procedures. Michael Medoff Page 13 of 18
14 5.15 The safety planning for the modification of safety-related software shall include identification of staff and specification of their required competency. (Part 3, a) This identification of staff is documented in the issue tracking system. Required competency is not specifically documented, but the changes were made by experienced developers from the original development team The safety planning for the modification of safety-related software shall include a detailed specification for the modification (Part 3, Section b) This information was included in the issue tracking system and the impact analysis document The safety planning for the modification of safety-related software shall include verification planning (Part 3, Section c) This information was included in the impact analysis document The safety planning for the modification of safety-related software shall include the scope of re-validation and testing of the modification to the extent required by the safety integrity level. For SIL 3 entire system must be revalidated. (Part 3, Section d) The impact analysis stated that the entire system would be revalidated Modification shall be carried out as planned (Part 3, Section ) Documentation in the issue tracking system showed that all of the work was carried out as planned Details of all modifications shall be documented, including references to the modification/retrofit request (Part 3, Section a) The impact analysis references the modification request via the issue ID from the issue tracking system (Unique identifier for each software change request) Details of all modifications shall be documented, including references to the results of the impact analysis which assesses the impact of the proposed software modification on the functional safety, and the decisions taken with associated justifications; (Part 3, Section b) The impact analysis documentation contains this information. Michael Medoff Page 14 of 18
15 5.22 Details of all modifications shall be documented, including references to software configuration management history (Part 3, Section c) The software configuration management history is documented and stored in the version control system Details of all modifications shall be documented, including references to deviation from normal operations and conditions (Part 3, Section d) This was documented in the impact analysis Details of all modifications shall be documented, including references to all documented information affected by the modification activity (Part 3, Section e) The impact analysis included a listing of all documents that would be updated based on this change Information (for example a log) on the details of all modifications shall be documented. The documentation shall include the re-verification and revalidation of data and results. (Part 3, Section ) Details of all modifications are included in the impact analysis and the issue tracking system. Documentation exists for re-verification (test reports, review reports, and static analysis results) and re-validation (test reports) The assessment of the required modification or retrofit activity shall be dependent on the results of the impact analysis and the software safety integrity level. (Part 3, Section ) The assessment of the modifications was based on the results of the impact analysis Michael Medoff Page 15 of 18
16 5.27 Hardware Assessment No hardware changes were made, so no assessment of the hardware is required. Michael Medoff Page 16 of 18
17 6 Terms and Definitions Fault tolerance FIT FMEDA HFT Low demand mode PFD AVG SFF SIF SIL SIS Type A (sub)system Type B (sub)system Ability of a functional unit to continue to perform a required function in the presence of faults or errors (IEC , 3.6.3) Failure In Time (1x10-9 failures per hour) Failure Mode Effect and Diagnostic Analysis Hardware Fault Tolerance Mode, where the frequency of demands for operation made on a safetyrelated system is no greater than twice the proof test frequency. Average Probability of Failure on Demand Safe Failure Fraction summarizes the fraction of failures, which lead to a safe state and the fraction of failures which will be detected by diagnostic measures and lead to a defined safety action. Safety Instrumented Function Safety Integrity Level Safety Instrumented System Implementation of one or more Safety Instrumented Functions. A SIS is composed of any combination of sensor(s), logic solver(s), and final element(s). Non-Complex (sub)system (using discrete elements); for details see of IEC Complex (sub)system (using micro controllers or programmable logic); for details see of IEC Michael Medoff Page 17 of 18
18 7 Status of the document 7.1 Liability exida prepares reports based on methods advocated in International standards. Failure rates are obtained from a collection of industrial databases. exida accepts no liability whatsoever for the use of these numbers or for the correctness of the standards on which the general calculation methods are based. 7.2 Releases Version: V1 Revision: R2 Version History: V1, R2: Updated HW and SW revision numbers; July 1, 2008 V1, R1: Updated based on comments; June 18, 2008 V0, R1: Draft; June 9, 2008 Authors: Michael Medoff Review: V0, R1: Iwan van Buerden; Release status: Released to customer 7.3 Future Enhancements At request of client. 7.4 Release Signatures Iwan van Buerden, Director of Engineering Michael Medoff, Senior Safety Engineer Michael Medoff Page 18 of 18
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